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Helping to Place the Pieces Together Through Leadership, Policy, and Financial Support The NHIA Future of Infusion Advisory Council (FIAC) brings together outstanding manufacturing and service companies who have pledged leadership, policy, and financial support to the National Home In fusion Association (NHIA). The Council works closely with the NHIA Board, leadership staff, and provider members to address the most critical issues, opportunities and challenges facing the home and specialty infusion industry—and this publication provides informative organizational profiles for each of the 10 2012 – 2013 FIAC member companies.

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Page 1: Helping to Place the Pieces Together - NHIA · oneer in the commercial manufacture of intravenous solutions, the company with more than 50,000 employees world ... While the company

Helping to Place the Pieces Together Through Leadership, Policy, and Financial Support

The NHIA Future of Infusion Advisory Council (FIAC) brings together outstanding manufacturing andservice companies who have pledged leadership, policy, and financial support to the National Home In­fusion Association (NHIA). The Council works closely with the NHIA Board, leadership staff, and providermembers to address the most critical issues, opportunities and challenges facing the home and specialtyinfusion industry—and this publication provides informative organizational profiles for each of the 102012 – 2013 FIAC member companies.

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In AppreciationOn behalf of the NHIA membership, we would like to extend our deepest appreciation to the membersof the association’s Future of Infusion Advisory Council (FIAC) for supporting our mission to be the tradeassociation that truly represents the home and specialty infusion community. The FIAC brings togetheroutstanding manufacturing and service companies who have pledged leadership, policy, and financialsupport to NHIA—and to advance our industry.

As part of NHIA’s efforts to broaden its connection to include all key stakeholders—providers, as wellas supporting businesses—we invited these companies to join in a unique partnership that has strength­ened the association immensely. FIAC companies join with NHIA’s provider­based Board of Directors toaddress the most critical issues, opportunities and challenges facing the industry. In a formal processthat was launched in 2008, the FIAC engages regularly with the Board in a strategic planning processthat sets NHIA’s course for successfully navigating the future.

The myriad results have been gratifying on a number of levels. Not only have we improved the field forhome infusion providers and supporting businesses alike, we have created a forum for dialogue thathas increased understanding on both sides. We believe that this new depth of cooperation has improvedthe innovation of product and service offerings to meet the dynamic needs of providers in the field, aswell as building a trust and appreciation for partners in the marketplace.

The financial support and guidance provided by the FIAC have strengthen the association and allowedus to address some critical long­standing needs, such as the NHIA Industry­Wide Data Initiative and acomprehensive study of home infusion service and reimbursement—foundational elements in the drivefor a meaningful Medicare benefit. There is no question that with the help of the FIAC members, NHIAand the entire alternate­site field is better positioned to succeed in the dynamically changing future ofhealth care delivery.

By stepping forward, the 10 FIAC members featured in this publication have demonstrated theircommitment and leadership to the field—and, thereby, fortifying our collective future. We invite youto learn more about their involvement with NHIA, and support them whenever you can.

Mary Cope, R.Ph. Russell BodoffChair NHIA Board of Directors NHIA President & CEO

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Table of Contents

FIAC Profile*..........................................Page NumberBaxter Healthcare Corporation........................................2B.Braun Medical, Inc. ........................................................4Cubist Pharmaceuticals, Inc. ............................................6Hospira Worldwide, Inc. ...................................................8Innovatix, LLC ..................................................................10Managed Health Care Associates, Inc. ...........................12Medical Specialties Distributors, LLC ............................14Moog Medical Devices ....................................................16Octapharma USA .............................................................18Smiths Medical................................................................20

*Note: NHIA had final editorial control over all material in this publication.

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Much like the alternate­site infusion field, Baxter Interna­tional Inc., is built on a long history of innovation. As a pi­oneer in the commercial manufacture of intravenous

solutions, the company with more than 50,000 employees world­wide has advanced life­saving products and therapies for morethan 80 years.

While the company has global reach, it understands the distinc­tive needs of its customers in home infusion and specialty phar­macy because it interacts so closely with them. “We recognize thatthe home care business model is different than an acute care setting,” explains Ivan Forehand, Director, National Accounts,Alternate Site, for Baxter’s U.S. Medication Delivery business. Forehand notes that the company’s contracting, inventory,and other business functions ensure that home infusion accounts receive the same level of support.

“Our dedicated alternate care sales team offers a single point of contact to work with our home infusion customersto provide expertise as needed,” he continues. “They understand the needs of the pharmacy and the home care pa­tient, which allows for robust problem solving.” The Baxter team’s expertise can range from training on products toproviding clinical resources and services. “As part of our Clinical Center of Excellence, we offer pharmacist­to­phar­macist consultations and product specialists who can provide a higher level of consultative interaction for specificpharmacy products,” he explains.

Meeting the Needs of the MarketHaving a long history of servicing the home infusion market has allowed Baxter to develop several products designed withease of use and safety in mind. “Our focus comes from being a major supplier of sterile products going into patient’s homes,hospitals, clinics, and physician’s offices,” observes Dennis Schneider, Vice President of Marketing for U.S. Medication De­livery – Pharmacy Operations, Baxter Healthcare Corporation. In addition to bringing new products to market, Baxter hasa track record of innovating through expansion and improvement.

“The Baxter product portfolio has been refined to meet the customer’s needs with emphasis on the areas of nutritionand drug delivery,” adds Forehand.

The SIGMA Spectrum Infusion System is a good example, according to Schneider. “With second generation smart tech­nology, it’s easy to program and offers several enhanced safety features.” Drug libraries and dose error reduction softwareprotect patients and programmers from errors, he says. “It’s a precise, modern system that works in the home setting.”

Another product line that improves care for home­based patients is shelf­stable CLINIMIX sulfite free (Amino Acids inDextrose) Injections, parenteral nutrition product. “For patients who can take advantage of these pre­mix solutions, CLIN­IMIX is a convenient option,” says Schneider. “It simplifies the process since refrigeration isn’t an issue. The added flexibilitycan afford a lifestyle change, which for patients depending on parenteral nutrition every day is significant.”

Baxter’s expertise in nutrition support—and safer IV dose preparation—was greatlyenhanced in 2011 when the company purchased Baxa Corporation, makers of advancedautomated compounding systems. “Both the Institute for Safe Medication Practicesand the Joint Commission recommend using automated compounding systems whenmaking custom complex intravenous therapies such as parenteral nutrition,” Schnei­der notes. “Acquiring Baxa strengthens Baxter’s commitment to nutrition as well aspatient safety and allows us to offer more solutions for the safe preparation and de­livery of IV medications.”

FIAC ProfileBaxter Healthcare Corporation

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Because it has a major pres­ence in the acute care marketas well, Baxter is well preparedto assist in patient care acrossthe continuum. “We work ef­fectively across the spec­trum of health caresettings,” observes Schnei­der, “and see a clear trendto moving more care to theoutpatient and home caresettings.”

“We help hospital pharmacies transition and manage pa­tients as they’re discharged to the alternate­site or home,”adds Forehand, noting that many of the company’s productofferings are designed to help manage patients needingcontinued medication and tracking to ensure compliance.

He cites the INTERMATE and MINI­BAG PLUS containersystem as examples. “These are two user­friendly productsthat allow patients to easily administer antibiotics while pro­viding the pharmacy a safe and cost­effective deliverymethod to support home therapy,” he explains. “We alsohave created patient guides that our home infusion cus­tomers can provide to their patients on proper use of cer­tain products.”

Responding to the Need for ChangeWhile the backdrop continues to shift, the past several yearshave brought additional pressures to bear on health care de­livery. Drug shortages and compounding practices are now“landscape items,” according to Schneider. “One thing Bax­ter does well is respond to the need for change,” he asserts,explaining that the company has been on the forefront of ad­dressing these clinical and operational challenges.

“When Baxter acquired Baxa, we became even more ac­tive in educating pharmacists on safe practices—and howto examine themselves and their facilities with a renewedperspective on patient safety,” continues Schneider. “Thismessage is underscored at our Star Center training facility,which offers hands­on training for leadership in best prac­tice sterile compounding in a state­of­the­art facility.”

Active LeadershipIn addition to providing leadership in times of immediateneed, Baxter is involved in shaping the future of the in­dustry. “We understand that providers are evolving in re­sponse to the changing health care landscape and themovement of care into the home,” says Forehand.“They’re seeking to move to integrated care models thatspan the entire value chain, including care into the homeand other alternate sites.”

Baxter is responding to these needs by innovating differ­entiated products and by focusing on services across thecontinuum. But the company also sees the benefit of col­laborating with the alternate­site infusion field as changestake place. “We greatly value the collaboration we have hadwith NHIA as the leading association in the home infusionindustry,” he says.

Baxter has been an active participant on NHIA’s Future ofInfusion Advisory Council (FIAC), remaining closely involvedin the organization and setting a direction for the industry.“NHIA and Baxter share a common commitment of meetingthe needs of the growing home patient population,” con­cludes Forehand.

For more information on this valued FIAC member,please visit: www.baxter.com

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Health care delivery is increasingly taking place outside thehospital walls. This trend is apparent to Bethlehem, Penn­sylvania­based B. Braun Medical Inc. (B.Braun), a global

company specializing in infusion therapy and pain management.“In the U.S., and globally, the outpatient market is a focus forB.Braun,” says Don Nymberg, Vice President of the company’sOPM (Outpatient Markets) Division. “We are committed to provid­ing the highest­quality products and services to our customers inthis marketplace,” he adds, noting that this is the primary vehiclefor bringing value to providers in the home infusion therapy and specialty infusion field.

Sharing ExpertiseAccording to Nymberg, B.Braun has helped shape the home infusion therapy market for decades by using expertise andexperience gained in both inpatient acute care and outpatient settings to create a line of innovative, safe, high­quality,easy­to­use products and services specifically designed for the home and alternate­site use.“We have a very diversified product portfolio that can be used in different settings and wecan tailor our products to meet the needs of our customers in the home infusion and al­ternate­site setting,” he observes.

“B.Braun also has a team of sales representatives and national account represen­tatives dedicated to the home infusion market, who consult with our customers ona routine basis,” Nymberg continues, noting that the company prides itself on un­derstanding the challenges and opportunities facing its customers.

“Appreciating the needs of customers builds relationships and adds value,” saysNymberg. A prime example of B.Braun’s focus on adding value is its automated com­pounder, Pinnacle®, which has gained a much larger footprint over the years in the out­patient setting. “The system includes Trissel’s™ Ca/P graphical compatibility curves, whichwere developed in collaboration with national drug compatibility expert, Lawrence Trissel, R.Ph., to address calcium/phos­phate compatibility in an effort to reduce potential errors,” explains Nymberg. “Clinicians have checks and balances through­out the entire total parenteral nutrition (TPN) process resulting in a high level of efficiency, accuracy, and safety,” he adds.

B.Braun understands the level of expertise required to deliver clinical excellence, adds Nymberg, and the company isdedicated to supporting that expertise in a variety of ways. “Our dedicated teams follow the business markets and have ahigh acuity on how patients interact in the home setting,” he explains.

“B.Braun also has a home infusion website (www.hit.bbraunusa.com), which provides its customers with an overviewof our product offerings, services, and industry resources—all of which underscores our Sharing Expertise® philosophy.”The website, designed as a nexus of knowledge, offers quick access to information about specific industry issues or in­depth educational materials on essential topics like compliance with USP <797>.

On the Horizon“The alternate­site infusion field faces a number of significant issues,” continues Nymberg. He cites clinical issues such asdrug shortages and safe compounding practices, as well as overall health care trends, such as shrinking reimbursement

FIAC ProfileB.Braun Medical, Inc.

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and the need to control spiraling health costs through de­livery system reform. “Our customers in the alternate­sitefield are constantly trying to figure out what the ultimateimpact will be. We can share our expertise with the infusionindustry by incorporating our knowledge and experience inall markets into the conversation,” he offers.

In addition to bringing a broader perspective to thetable, B.Braun offers solutions that can help providers re­duce costs and improve their practice—two of the mostpressing needs in health care today. “B.Braun is commit­ted to IV therapy and continues to invest in the develop­ment of products and services to support thatcommitment,” asserts Nymberg.

“One of the trends that remains a strong challenge forthe entire health care industry is the difficulty in findingenough skilled workers to treat an influx of patients createdby the aging population,” he observes, noting that this isespecially concerning in home care because the setting iswidely recognized as a lower­cost alternative and the pref­erence of most patients. “Modifying our education andtraining services to make it easier and faster for clinicians tocomplete their training has become a major focal point atB.Braun,” he continues.

Realizing that providers face challenges finding, training,and retaining qualified nurses and pharmacists—and haveto accomplish more with a smaller staff—B.Braun boxed upits education and training services to make them easier andquicker to use. Customers can now access information ondevices, essential industry issues, and even clinical continu­ing education electronically. “Providing education and train­ing solutions gives us an opportunity to help ourcustomers in the home infusion industry meetgrowing business demands,” says Nymberg.

Reimbursement pressures also chal­lenge effective delivery of services inthe home. Medicare reimburse­ment for home infusion therapy issomething that the FIAC hasworked on over the years.

Seat at the TableAn important component of B.Braun’s outpatient marketfocus is the company’s longtime participation in and sup­port of NHIA and its programs, including the Future of Infu­sion Advisory Council (FIAC). “B.Braun values its partnershipwith NHIA, says Nymberg. “We are proud to be one of theindustry leaders participating in the FIAC.”

Contributing at the leadership level is important to thecompany, because it provides a window to the issues facingthe field as well as an opportunity to share B.Braun’s ownperspective—the result of years serving the entire healthcare spectrum. “Taking part in the FIAC’s meetings, wherebroad issues are explored in the context of industry strategyand direction, is critical,” observes Nymberg. “It gives us avoice and builds relationships.”

B.Braun has cultivated a longstanding dialogue withcustomers and key industry leaders and stakeholders,says Nymberg, and engaging with NHIA at the leadershiplevel only enhances those efforts. “These interactionswith providers and other manufacturers and serviceproviders increases our understanding of the market anddeepens the exchange of ideas that’s so essential to suc­cess,” he observes.

“Our customers know we are engaged and that we un­derstand their business at the granular level,” Nymberg con­tinues. “The challenges of health care often transcend areasof care, so we feel it’s important to take our experiences inall markets and use it to provide knowledge and value toour customers.”

Trissel’s is a trademark of Lawrence A. Trissel, R.Ph.

For more information on this valued FIAC member,please visit: www.bbraunusa.com

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Cubist Pharmaceuticals describes itself as a bio­pharmaceutical company fo­cused on the research, development, and commercialization, of pharmaceuticalproducts that address unmet medical needs in the acute care environment.

And while the company’s focus on development of novel therapies is designed tobenefit patients in hospitals and other acute care environments, they are no strangersto the alternate­site infusion field.

Headquartered in Lexington, Massachusetts, Cubist is best known in the outpatientsetting for marketing CUBICIN® (daptomycin for injection). The company’s clinicalproduct pipeline currently consists of a Phase 3 program focused on the developmentof a novel cephalosporin to address certain serious infections caused by multi­drugresistant (MDR) gram­negative organisms, a Phase 3 program for the treatment ofClostridium difficile­associated diarrhea (CDAD), and a Phase 3 program for the treat­ment of chronic opioid­induced constipation (OIC). Cubist also is working on several pre­clinical programs to address areasof significant medical needs, including therapies to treat serious bacterial infections and acute pain.

So Much to GAINWith a research pipeline so focused on fighting infection, Cubist has been closely involved in addressing the public healththreat caused by a growing array of MDR bacteria. This group, called “gram­negative” bacteria, is particularly dangerousbecause they are very quick to develop resistance to current treatments. According to Centers for Disease Control and Pre­vention (CDC) data, more than 1.7 million people acquire bacterial infections in U.S. hospitals each year—and 99,000 peopledie as a result of these bacterial infections, of which up to 70% are resistant to at least one drug.

Health care providers are facing a dwindling supply of medical weapons to fight these deadly foes. And, while efforts areunderway to promulgate best practices that incorporate proper stewardship of existing antimicrobial therapies, developingnew tools to replenish the dangerously low inventory is critical to successfully ensuring public health.

However, developing new therapies is not without its challenges. It takes researchers an average of 10 years to bring asingle product to market, and the financial incentives are low given that antibiotics are prescribed for such short periodscompared to drugs that treat chronic conditions.

To address the growing health threat, Congress passed the Generating Antibiotics Incentives Now (GAIN Act), which wassigned into law in 2012 as part of the Food and Drug Administration Safety and Innovation Act. Cubist was closely involvedin the development and passage of the GAIN Act, which incentivizes research and development and streamlines the FDAregulatory review process. Passage of this legislation represents a significant achievement not only for Cubist, but for healthcare providers and patients across the continuum.

“Without the GAIN Act, it would be significantly more difficult to develop new antimi­crobial products for home infusion providers to utilize,” observes Mark T. Battaglini,Esq., Vice President of Government Affairs at Cubist. With antibiotics representing asignificant percentage of home infusion therapies, providers and patients alike relyon a robust pipeline of drug agents, he points out.

Bringing it HomeCubist understands the critical role home infusion plays in quelling the spread of infectionand battling resistance, according to Battaglini. “It’s one of the most cost­effective set­

FIAC ProfileCubist Pharmaceuticals, Inc.

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tings of care, not to mention there are high rates of patientsatisfaction and quality of life standards along with a re­duced risk of nosocomial infections when you treat a pa­tient outside the hospital,” he says. “We understand thatso many of the health care reform changes coming throughare based on moving patients from the acute care to out­patient setting.”

“Yet, in many parts of the country, because of a lack ofMedicare coverage, patients are sitting in clinics or spendingtime in acute care or skilled nursing facilities when theycould be getting treatment at home,” continues Battaglini.This is one example of common ground between Cubist andNHIA members, he points out. Another is showing value.

Home Infusion provides a good opportunity, explainsBattaglini. “It can help reduce length of stay by providingquality care in the home —that’s meaningful.” At the sametime, he adds, that value can only be realized through thehands of skilled professionals and a cadre of related prod­ucts and services required to safely and effectively admin­ister the therapy.

Payers, including the Centers for Medicare & MedicaidServices (CMS) could better understand the impact of theirdecisions by considering value in the context of the biggerpicture. Battaglini points to the Medicare Competitive Bid­ding Program as an example. “Getting the lowest price ona pump does not necessarily save money when you look theentire cost therapy,” he explains. “They’re not looking atthe whole puzzle, just a few pieces.”

On the commercial side, a deeper understanding of thevalue of home infusion might prompt payers to hold downrising patient co­pays and deductibles to encourage utiliza­tion of overall cost­effective settings. “If a patient choosesinpatient care because the daily co­pay at home is too high,the larger savings are missed,” he explains.

We need to demonstrate value by collecting and sharingdata, observes Battaglini. “We have to be able to show sav­ings from across the spectrum in areas such as reducedreadmissions and hospital avoidance.”

Partners in ChangeData collection and payer education are important pillars ofNHIA’s strategic plan, which was developed with the inputof the association’s Board of Directors and Future of Infu­sion Advisory Council (FIAC). This type of common grounddrew Cubist to participate in the FIAC, says Battaglini.“Working with NHIA is a priority because we are focused on

the same end users as your members, the patient who is ill,”he acknowledges, “but there are also opportunities for usto educate one another.”

Education is especially important as health care reformchanges are made and the overall health care environmentchanges, according to Battaglini. “You can come willingly oryou can kick and scream, but change is coming and under­standing it is the key to success.”

For more information on this valued FIAC member,please visit: www.cubist.com

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As infusion providers continue to seek out new ways to work across thechanging health care continuum, it’s important to partner with support­ing businesses that have a big­picture view and the ability to leverage

their expertise and resources. Headquartered in Lake Forest, Illinois, Hospira,Inc., does just that by developing, manufacturing, and marketing products cre­ated to help improve the productivity, safety, and efficacy of patient care in allsettings. The company offers a broad line of generic specialty injectables, andintegrated solutions for medication management and infusion therapy. In itsnon­acute business, Hospira has a long history of commitment to supportingthe home and alternate­site infusion therapy field.

Aligning with Alternate-Site Infusion“We strive to understand our customers and their needs,” explains Paul Catenaro, Director of National Accounts Salesand Marketing for Hospira’s non­acute business. “That helps us provide value in our product portfolio, and it allowsus to harness a large knowledge base and put it to work for infusion and specialtypharmacy providers to create a greater benefit in the end.”

Having a diverse selection of products backed by a dedicated sales and marketingteam is key to Hospira’s close alignment with the alternate­site infusion field, accord­ing to Catenaro. “We are able to connect with other non­acute markets, such as long­term care, oncology, and surgery and dialysis centers, as well as leverage our largehospital­market resources when necessary,” he says.

There is also a lot of cross­pollination within Hospira itself as individuals moveacross business groups. “With the emergence of accountable care organizations(ACOs) and other integrated delivery systems, there will be more and more overlapin these markets, and that kind of cross­expertise will be priceless,” continues Cate­naro.

Catenaro asserts that Hospira’s “one­stop­shop” for drugs and devices is continually evolving to meet customer needs.“As the leading provider of generic injectables, we are on the forefront to launch a host of new products as the genericmarket opens up,” he explains, noting that generic offerings can reduce expenses throughout the system. “We are wellpositioned to reduce costs, especially with our push into globalization where we can realize economies of scale.”

That global involvement in health care provides perspective as well, according to Catenaro. “We were recently at a con­ference that included the launch of an infusion device for use in another country,” he recalls. “Our team took time to notethe similarities between our home infusion customers in the U.S. and other markets so we can apply customer input andlessons learned to the rollout of that product when it becomes available here.”

In addition to looking down the road, Catenaro makes it clear that, despite industry­wide drug shortages, recalls, andother supply disruptions, Hospira remains steadfast in the here and now. “We are addressing these challenges by makingclear and substantial investments to “fix the foundation” across our manufacturing operations. We’ve come a long wayand made good progress,” he explains.

While the company strives to return to its strong supply record, Catenaro asserts that its actions demonstrate that,“We’re in it for the long haul.” He points to Hospira’s proactive industry communications and contingency planning

FIAC ProfileHospira Worldwide, Inc.

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around market shortages. “We are committed to our cus­tomers and their patients,” he continues, noting that Hos­pira provides alternatives whenever possible.

Embracing ChangeHospira’s close alignment with the alternate­site marketoffers several advantages, according to Catenaro. “Oursales force is always looking to find areas of potential sav­ings for customers,” he explains. “They also connect uswith the market and the continuum as a whole, whichhelps everyone better prepare to complement market­place change.”

Hospira’s presence in hospital and home infusion mar­kets—as well as surgery centers and oncology markets—can help tie a great deal together, says Catenaro. “Wealready have products in place on both sides of the con­tinuum. The ability to go back and forth provides the typeof continuity needed for safe, cost­effective patientcare,” he explains.

For years Hospira has been putting people and ideas to­gether in other non­acute areas. “We are just starting toscratch the surface with home infusion,” observes Cate­naro. He anticipates the need for more cross­market in­volvement as health care delivery models evolve and thelines between sites of care blur.

“Biosimilar drugs are a great example,” Catenaro pointsout. “There are many medications that are currently beingadministered in a physician’s office now, but may move tothe alternate site. Our team is watching to better under­stand how those drugs are used and reimbursed, so whenthey are poised to shift, we can assist home infusionproviders in tapping into new markets.”

Smart pumps and information technology are another casein point. “As ACOs and other integrated systems grow, pa­tients will need to be connected across sites of care and in­formatics will become more important,”Catenaro explains. “Today’s smartpumps already possess many ofthose necessary data collec­tion functions. We’re lookingat how we can tie it all to­gether to provide value forthe customer.”

Partnering with NHIAData is also increasingly important in demonstrating thequality and value of health care services. Hospira under­stands this and supports NHIA’s Data Initiative as a rallyingpoint for the industry. “There’s a cross­section of the infu­sion industry driving that project, which will eventually ben­efit everyone,” observes Catenaro. “Hospria is alwaysexcited to be involved with projects where providers andsupporting businesses can pool their resources to make abigger impact.” The result is better because there’s diver­sity of thought behind a united voice, he adds, pointing tothe combined advocacy efforts that have taken place.For this reason, Hospira supports NHIA through a variety ofprogram sponsorships as well as active participation in theFuture of Infusion Advisory Council (FIAC). “We are veryproud of our involvement with NHIA,” says Catenaro, “andwe receive great value from it as well.” In addition to havingan opportunity to share perspectives on market develop­ments, the FIAC invites members to participate in the dia­logue about how the association prioritizes and respondsto key issues.

“The strategic planning sessions provide an insider’s viewof what providers experience on a daily basis—that insightis invaluable,” explains Catenaro. “The process also pro­vides a vision of the future, key issues facing the member­ship, and an important opportunity for feedback.”

Catenaro adds that Hospira is also impressed with the as­sociation initiatives that are developed in that forum andcome through the Board of Directors. “Having those bodiesworking together accelerates moving the field of home in­fusion forward.”

Forward is the only way to go for an industry with such abright future, he adds. “Reimbursement pressures aside,we see medicine going in the direction of the alternatesite,” concludes Catenaro. “So we are committed to foster­ing strength and growth in this segment of health care.”

For more information on this valued FIAC member,please visit: www.hospira.com

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Often, the best way to effect change is to achieve a powerfulvoice within the system. For 20 years, Innovatix, a NewYork­based group purchasing organization (GPO), has

worked to transform the traditional GPO model. The company hassuccessfully developed a comprehensive value­added services pro­gram that includes government affairs, clinical services, and edu­cation, allowing members to focus on what they do best—providethe highest quality of care for the communities they serve.

Group-Purchasing AgentsInnovatix offers contracting solutions for the non­acute care marketplace, including senior living facilities, independent physi­cian and oncology practices, and specialty, home infusion, retail, mail order, and long­term care pharmacies. Currently servingover 17,000 members nationwide, Innovatix provides access to a portfolio of savings negotiated by leveraging a total pur­chasing volume of over $45 billion.

“Our primary function is to help our members with their cost of goods sold (COGS) by making acquisition costs as low as possi­ble,” says Walter S. Geba, Pharm.D., Senior Vice President of Contract Services and Chief Pharmacy Officer. Innovatix membershave access to over 14,000 contracted pharmaceutical products, as well as added savings on an extensive medical/surgical portfoliothrough its affiliation with Premier.

Innovatix is 50% owned by Premier, one of the nation’s largest acute care GPOs. Geba explains, “Our relationship withPremier allows our members to access some of the same discounted pricing that was typically only available to the nation’slargest acute care institutions,” he says. Innovatix brings further value to members by coordinating regional and nationalaggregation programs and “Group Buys.” Moving beyond the typical GPO model, Innovatix’s aggregation projects requirea precommitment from members in order to secure unique one­time contracted pricing on a specific set of products orservices. “Once a member commits to a particular group buy program, we facilitate the bid process with the vendor com­munity on their behalf,” Geba says. This precommitment frequently allows Innovatix to negotiate more favorable pricing.

Innovatix also offers a web­based tool, called Contract Advantage, that allows members to see the financial comparisonbetween using a non­contracted drug and a contracted drug for a given Food and Drug Administration (FDA)­approved in­dication. It compares contract prices, reimbursements, wholesaler acquisition costs (WAC), average wholesale price (AWP),and/or average sales price (ASP).

Reimbursement AgentsIn addition to Contract Advantage and other reimbursement structures, the Innovatix Network, a subsidiary of Innovatix,helps home infusion pharmacies navigate Medicare Part D. “Innovatix has designed a specific Medicare Part D networkdedicated to serving home infusion pharmacies,” observes James V. Vasquenza, Jr., Vice President, Innovatix Network.Recognizing that reimbursement is a core issue for outpatient providers, the Innovatix Preferred Provider Network (PPN)was established to facilitate new relationships with Prescription Drug Plans (PDPs) under the Centers for Medicare andMedicaid Services (CMS) Medicare Part D program.

Today, the Innovatix PPN offers a range of programs and services, including access to Medicare Part D contracts with thenation’s largest regional and national prescription drug plans (PDPs) and pharmacy benefit managers (PBMs), dispensing feesand AWP discounts, and access to regularly published electronic newsletters and updates. Moreover, the Innovatix Networkhas a dedicated staff to assist with contract attachment, claim adjudication, prior authorizations, third­party audits, creden­tialing, and other challenges.

FIAC ProfileInnovatix, LLC

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Education and Clinical AgentsOne of the most unique aspects of the Innovatix group pur­chasing model is its clinical infrastructure. There are 12 staff cli­nicians dedicated to supporting both members and regionalsales representatives in the field. “With specialists in pharmacyoperations, oncology, infectious disease, managed care phar­macy, and acute care pharmacy, we are well positioned to helpour members provide the best care possible,” asserts Geba.These experts keep members abreast of best practices, clinicaltrials, drug information, medication safety, formulary manage­ment, and more through several distinct platforms.

Innovatix Care Solutions are disease state managementguides. Created by the clinical team, they educate Innovatixmembers and provide resources that support member dis­ease management initiatives. This program includes compre­hensive manuals on type 2 diabetes, deep vein thrombosis,and anemia. Each guide includes patient assessment tools,policies and procedures, care plans and physician consult re­quests, medication selection guides, dosing equivalentcharts, protocols for identifying and managing complications,as well as references for treatment and monitoring.

As an approved Accreditation Council for Pharmacy Edu­cation (ACPE) provider, Innovatix is also able to offer mem­bers complimentary accredited Continuing Education (CE)programs. Innovatix’s flagship Lunch ‘N Learn program is afree monthly teleconference series designed for the long­term care and infusion provider markets. Innovatix also pro­vides live CE programs at its annual National Meeting andLegislative Conference. Past meetings have offered mem­bers up to 18 accredited programs. Innovatix also publishesInsight, a biannual magazine that is distributed directly toall Innovatix members and contains an accredited self­studyCE course.

Change AgentsInnovatix is dedicated to keeping its finger on the pulse oflegislative and regulatory developments. “One of our par­ent organizations, the Greater New York Hospital Associa­tion, has a rich history of advocacy work,” explains John P.Sganga, President and CEO of Innovatix. “We have an in­depth understanding of how regulations can affect ourprovider members’ businesses.”

The Innovatix Government Affairs Program disseminatesinformation relating to clinical, business, and financial mattersthat impact the ability of non­acute care providers to deliverquality care to their patients. Working with the DumbartonGroup and Associates, an advocacy firm based in Washing­ton, D.C., Innovatix monitors legislation closely, from incep­

tion to implementation. In addition to monitoring regulatoryand legislative developments, the Government Affairs pro­gram provides timely and substantive updates to membersthrough emails, conference calls, and workshops. Innovatixalso hosts an annual Legislative Conference that brings to­gether industry leaders and policy experts to equip attendeeswith the necessary tools as they meet with their respectivecongressional leaders on Capitol Hill.

Innovatix’s commitment to keeping members informedand up­to­date on regulatory and legislative developmentsis what first brought the GPO and NHIA together severalyears ago when the Medicare prescription drug benefit wasfirst announced. “We support NHIA’s efforts and recognizethat home infusion therapy encompasses more than justthe acquisition cost of drugs. Helping to make Congressaware of the current gap in coverage and subsequent prob­lems involving patient access is key to our partnership withthe association,” states Geba.

As a member of NHIA’s Future of Infusion Advisory Coun­cil (FIAC), Innovatix has pledged to support the industry andthe association with leadership, policy, and additional finan­cial support.

Strategic OutlookInnovatix is strategically positioned to adjust contractingstrategies in order to stay responsive to our members’changing needs. For example, as the infusion industry con­tinues to grow and diversify, many infusion providers arelooking to enter into the specialty market. Innovatix, in col­laboration with the Innovatix PPN and Premier, offers anaggressive purchasing program for specialty pharmacyproviders. “By leveraging 20 years of contracting experi­ence, and by working closely with our members to targetkey specialty product lines, we’ve been able to offer mem­bers reduced pricing where it matters most,” explainsSganga. “We want to help our members keep their eyesopen about the possibilities and to know thatwe will continue to help legitimize theirconcerns while providing solutionsthat enable them to serve theircommunities successfully.”

For more information on this valued FIAC member,please visit: www.innovatix.com

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No one wants to choose between low cost and high quality.Fortunately, the members of Florham Park, New Jersey­based group purchasing organization (GPO) Managed

Health Care Associates, Inc. (MHA) have access to both.MHA has been in business for more than 23 years, and over the

last 10 years has offered its home infusion/specialty members accessto discounted pricing on products and services, such as pharmaceu­ticals, medical supplies, capital equipment and business solutions.But, through significant expansions in service lines, staffing, and cus­tomer base, the GPO has grown into an alternate site health care services company focused on nearly every aspect of the al­ternate­site infusion market.

“Our engine is buy side contracting and helping members reduce their costs, but we realize they have needs beyond that,”explains MHA President Michael J. Sicilian. “So we’ve expanded the traditional GPO contracting model to cover the full spec­trum of products and services our members use to support their operations.” In addition to GPO contracts with trade part­ners—many of which offer non­health­related business essentials, such as cell phone and courier service—MHA brings industryknowledge and experience that are the foundation for quality member support beyond simple cost savings.

High-Touch, Tenured Team“Our team has a very high level of expertise,” says Diane Koontz, Senior Vice President of MHA’s Alternate Site Care Division.With extensive knowledge in the market, MHA’s dedicated account management team works closely with members to en­sure their businesses are effectively managing purchasing and cost of goods. “The team utilizes robust reports and dataanalytics to find areas of improvement for customers,” continues Koontz. By examining purchasing patterns, the GPO canidentify savings through various contracts, identify alternative product choices, or offer prod­ucts and services that could save time or expenses in different areas. “Our role is toconsult with our members so that they can maximize savings and reduce costs,”she says.

That’s not possible without a deep understanding of and commitment to theindustry, adds Sicilian. “We have a tenured, experienced team that knows themarket,” he observes. “They share the “voice of the customer” in terms of whatthey are seeing and hearing in the marketplace, so we can better meet the needsof our customers.” Likewise, according to Sicilian, account managers are able toshare with customers, issues and larger trends MHA observes throughout its en­tire customer base.

Koontz points out that MHA further fulfills its consultative role by educatingmembers on a wide array of actionable items. A dedicated clinical staff tracksdrug shortages, drug recalls, new drug and product approvals, and other market devel­opments, offering updates and education. “Clinical education is essential,” says Koontz.“Our clinical team is well published on topics like specialty pharmaceuticals, new drug launches, information on patientassistance programs, information related to limited distribution networks and new drug pipelines.”

MHA educates its members on the legislative and regulatory aspects of delivering health care as well. “WhenMedicare announced that the Competitive Bidding Round 1 re­compete would include infusion pumps, we used severalinternal resources to inform members,” recalls Koontz. “We held webinars and sent out regular communications.”

FIAC ProfileManaged Health Care Associates, Inc.

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In fact, the increasingly complex legal and regulatoryenvironment has prompted MHA to bring on a dedicatedsenior advocacy staff member who can look at develop­ments in this area with a different lens. “The regulatoryenvironment is becoming more complex,” observes Sicil­ian who has been an involved advocate in the home infu­sion industry for years. “Our customers are out theretrying to get things done and facing all types of new re­quirements,” he says, citing stepped up Payer and RACaudits as one example. “These rules affect everyone andmeeting them requires resources.”

MHA members appreciate the GPO’s past advocacywork as well as its newest resource, according to Sicilian.“Having Susan Janeczcko, Pharm.D., J.D., join MHA in2012 as the Executive Director of Legislative Affairs reallyreinforced our commitment to our membership across allof our business lines.” She is well versed in the respectiveissues impacting the home infusion, specialty, long termcare, and HME members.”

It’s people like this—both inside headquarters and face­to­face with customers in the market—that make MHA dif­ferent­ Exceptional Service, Extraordinary People, Sicilianproudly asserts. “At the end of the day it’s a relationshipbusiness,” he observes. “We are a high­touch, customer­dri­ven organization.”

Partnering to Meet the Challenges Responding to customers means understanding the chal­lenges they face. “The most pressing issues for MHA mem­bers in alternate­site infusion mirror those faced in thebroader health care delivery industry,” Sicilian says. “De­clining reimbursement paired with an increasing regulatoryburden are putting extreme pressure on margins.” In theend, customers are looking for predictability, he explains,and with the pace and severity of changes within the sys­tem, that’s elusive.

“Everyone agrees thatthe health care system isin trouble and everyone istrying to make it better,”Sicilian continues. “Sincethis ties directly into the

challenges our members are facing, we are trying to workacross the delivery model to continue to educate all stake­holders on the value proposition of home infusion therapy.”Sicilian says MHA is a good partner to be educating pay­ers—both governmental and commercial—about the homeinfusion industry. “We don’t have an agenda per se, so it’smore objective, we want to see a healthy competitive envi­ronment. At the same time, Sicilian insists that, “No one cando this alone,” so MHA works to build valuable relationshipswith industry partners, such as NHIA. “NHIA representsmany of the same constituents, and most of the time weare on the same page regarding the issues,” he explains. Forthis reason, MHA has been active in, and supportive of,NHIA’s grassroots advocacy efforts for years.

The organization also supports NHIA through a variety ofprogram sponsorships and as an active member of the Fu­ture of Infusion Advisory Council (FIAC). “If you’re going toparticipate, the FIAC is the place to do it,” Sicilian proclaims.“We want to be involved at the leadership level.”

The FIAC is a unique platform, according to Sicilian.“The group represents a good cross section of the indus­try that’s critical to understand. It’s unique—each partic­ipant has their own objectives and goals, but there isconsistency in the issues and the approach.”

MHA finds value in having a seat at the table and achance to offer input, he adds. “It’s interesting to seehow the whole process develops. We want to be part ofdirecting strategy because we think we bring value to theprocess.” Sicilian notes that the benefits go both ways,noting that they learn a lot through participating.

“It’s a good relationship. We expect it to continue,” heconcludes. “We’ve listened to our members and they saythat supporting NHIA is important to them.”

For more information on this valued FIAC member,please visit: www.mhainc.com

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Medical Specialties Distributors, LLC (MSD), of Stoughton,Massachusetts, provides infusion therapy solutions tothe alternate­site market, offering a complete line of

medical products, high­quality biomedical services, and innovativetechnology solutions. The company has been a long­time staple ofthe home infusion market with origins dating back to 1984. Witha history of supporting NHIA, MSD strives to serve as an industryleader and key player in the alternate­site infusion therapy indus­try. The company’s business model combines a national footprintwith a state­of­the­art distribution network, solutions­focused methodology, differentiated customer services, and a fullsuite of products.

Total Enterprise SolutionMSD provides a comprehensive array of value added solutions through its “Total Enterprise Solution” approach to morethan 4,000 non­acute customers. The approach includes a complete Supply Channel Solution, consisting of a broad arrayof infusion­related disposable supplies and bio­medical equipment services, as well as value­added programs, such as for­mulary development, online ordering, billing services, equipment management and tracking, and patient­direct deliveryprograms. MSD provides a customer­centric focus with a wide selection of supplies and biomedical services for delivery ofpatient care within the alternate­site infusion therapy environment. The company’s infrastructure provides flexible homedelivery programs and same­day rental deliveries from seven full­service centers—all with customer convenience in mind.

“By partnering with MSD, our customers are able to improve operational effectiveness, resulting in increased pro­ductivity and lower cost of operations,” says Jim Beck, President and CEO of MSD. “We aggressively work to providea product and service portfolio that delivers the lowest cost of care with the ultimate goal of improving patient out­comes. This partnership methodology allows customers to outsource non­core activities to MSD so they can focus ondelivering the best in patient care.”

Tailored Product MixMSD offers a comprehensive line of health care supplies with a product mix specifically geared to the alternate­site infusiontherapy provider. The company’s portfolio of products and relationships with key manufacturers offers more than 15,000unique, industry­specific items, including: infusion administration sets, IV solutions, enteral devices, nutritional supplements,prefilled syringes, wound care products, clean room supplies, pharmacy products, needles and syringes, and surgical kits.

Building strategic relationships with key health care manufacturers has been critical to MSD’s long­term growth and success.The company has strong relationships with the leading product manufacturers in the industry. “Medical device manufacturersare selective when choosing partners,” explains Beck. “MSD’s strong relationships with these suppliers are evidence of thehigh­caliber services we provide.”

MSD also offers a comprehensive portfolio of group purchasing organization (GPO) agreements, providing customerswith enhanced access to a wide variety of medical devices and products at competitive price points. In addition, thecompany has an extensive line of more than 500 private label products offering home infusion providers high­quality,economical alternatives.

When it comes to infusion devices, MSD recognizes that providers need flexibility through a wide selection of productsand effective asset management. So, the company’s Biomedical Services provide multiple options with a device inventoryof more than 35,000 infusion pumps, ventilators, and patient monitoring equipment available for sale as well as short­ and

FIAC ProfileMedical Specialties Distributors, LLC

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long­term rental. Equipment service and repairs are per­formed by factory­trained technicians based in eight re­gional service and repair centers. MSD’s biomedicaloperation is also the only ISO­certified organization cateringto the alternate­site infusion therapy market.

“Our program delivers quality, consistency, and depend­ability across a customer’s entire fleet of equipment,” saysDennis Beatty, Vice President of Biomedical Operations andCapital Procurement for MSD. “Our quality system insurescontinuity and peace­of­mind for customers.”

MSD can also assist when customers are looking to up­grade their equipment. “Whether it is assistance withdevice selection, a rent, buy or lease decision, or sellingoff old under­utilized equipment, we are here to help,”adds Beatty. “With more than 25 years of experience inthe alternate­site infusion market, we work to leverageour knowledge and understanding to bring solutions toour customers.”

Innovative Technology Solutions andLogistical ExpertiseMSD strives to make partnering with them easy, and indoing so provides customers with productivity tools, suchas a web­based equipment tracking and management sys­tem, convenient on­line ordering capabilities, flexible soft­ware interfaces or multiple EDI (electronic datainterchange) transaction sets.

OneTrack® is MSD’s proprietary asset management andtracking system designed specifically for health careproviders. Combining web­based technology with provenmanagement processes, OneTrack® allows both single­siteand multi­site users to better manage their fleets of medicalequipment, devices, and accessories.

“With MSD’s OneTrack® Equipment Management System,users can manage their entire fleet of equipment from a sin­gle portal,” explains Richard Worthen, Executive Vice Pres­ident of Sales and Strategic Relations. “One Track® providesdevice tracking to reduce equipment losses, device utiliza­tion reporting tools, regulatory compliance documentationand tracking, collection of device service and repairs docu­mentation, cost of ownership comparisons and customizedreporting. Health care providers can now manage all theseoperations in just a matter of minutes—improving FTE effi­ciencies while lowering overall costs.”

MSD also has an exclusive alliance with a large home in­fusion industry software developer that delivers a host ofsupply chain management features. Through a software in­terface with MSD, users can easily manage patient dropshipments, bulk ordering, and asset management.

With an advanced distribution infrastructure, MSD offersa variety of customized solutions, including the flexible andcost­effective Patient Home Delivery program. “Leveragingseven strategically located distribution centers, MSD can de­liver supplies to patient homes in 48 hours or less to morethan 90% of the U.S. population,” explains Worthen.

“Our break­pack operation delivers a high fill rate com­bined with great accuracy of any fulfillment,” says Peter Huie,Vice President of Operations at MSD. “In the past year andhalf, MSD has upgraded and modernized all of our facilities,improving productivity and enhancing efficiency across ourdistribution infrastructure.”

Commitment to The FIACParticipating in the FIAC, which supports the NHIA Board ofDirectors in defining strategic priorities, has assisted MSD inaligning with the strategic imperatives important to the in­dustry. Each FIAC event, according to Worthen, “is an oppor­tunity for MSD to learn more about the current and mostpressing challenges that our customers are facing and whatwe can do to help overcome them.”

“The FIAC is extremely open and willing to share theircompany initiatives and innovation with the NHIA Board andwith each other,” continued Worthen. MSD is extremelyproud to be included in the FIAC membership.”

Alternate­site infusion therapy is a unique business thatrequires MSD to be flexible to meet the requirements oftoday’s customer and the needs of the changing health carelandscape. According to Beck, “MSD works closely withinthe field, continually seeking solutions that aid the industryand our valued customers. ”

“We are proud of our history and look forward to contin­uing to partner with leaders in the home infusion and healthcare products markets to bringinnovative solutions to fullysupport patient care in thehome,” said Beck.

For more information on this valued FIAC member,please visit: www.msdistributors.com

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Moog is a worldwide designer, manufacturer, and integra­tor of precision control components and systems. Since1951, it has developed and provided the critical compo­

nents necessary for aircraft navigation safety and helped to enablespace vehicles to explore the universe. Moog’s systems controlmilitary and commercial aircraft, satellites and space vehicles,launch vehicles, missiles, automated industrial machinery, and ma­rine applications. Careful attention to precision and detail is priorityin everything Moog does, from aerospace and defense to the ac­quisition and development of infusion and enteral therapy devices.

Moog’s expertise brings the medical market advanced technologies for the precision control of motion and fluids. Deliv­ering the precise, reliable control of fluid movement, simplifying processes, increasing safety and enhancing patient andcaregiver outcomes is a strength that Moog has applied to a range of medical pump technologies.

Through research and development, and the expertise of its people, Moog develops advanced infusion systems that im­prove medication safety, optimize application performance, and reduce medical expenses. Moog strives to simplify theprogramming and delivery of correct therapy dosages while enabling improved patient health and mobility. Our infusionand enteral products are used in both the inpatient and alternate­site infusion therapy settings.

Products and InnovationBetween 2006 and 2007, Moog acquired Curlin Medical and Zevex International, two infusion pump manufacturers alreadyestablished in the home and alternate­site infusion industry. These companies possessed expertise in clinical engineering,sales, and distribution. Combining the capabilities inherited from these organizations withMoog’s own resources enhanced existing products and services and brought aboutexciting new advancements in infusion therapy products.

The unique PainSmart® IOD™ (Information on Demand) and 4000/6000 ClinicalManagement System at­home infusion and ambulatory infusion pumps address theneed for precise, controlled delivery of infusion therapy drugs. Because they pro­hibit users from bypassing drug libraries and establishing default rate settings forcertain drugs, these pumps ensure the correct therapeutic medications are admin­istered at the correct dosages. The development of truly smart pumps has ad­dressed providers’ needs to deliver medications to patients at controlled rates andto adjust dosages as needed.

In 1996, Zevex entered the enteral feeding market with the EnteraLite® ambula­tory enteral feeding pump. This product was the result of an extensive research ef­fort that included soliciting customer input during the initial ideation stage as well as during productdesign and development. The result was a pump that offered accuracy and virtually unlimited mobility. In 2005, Zevex builton the achievement by launching its successor, the EnteraLite® Infinity, a smaller, more rugged and easier­to­use device.

With the purchase of Zevex, Moog was able to expand its reach into the ambulatory enteral feeding market. Further researchled to the development of the Infinity Orange®, an enteral­only feeding system that provides highly accurate small­volumefeedings. The Infinity Orange® improves patient safety by reducing programming errors and eliminating the possibility of mis­connections. These devices provide neonatal and pediatric populations precise and reliable enteral feeding options.

FIAC ProfileMoog Medical Devices

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Continued dedication to improved delivery of care is notrestricted to the infusion pumps Moog provides. Its focuson the development and provision of advanced softwarethat allows practitioners to more readily access treatmenthistory and data. The software’s strict drug protocols spec­ify and control administration of the required medicationwhile limiting alteration of specific infusion parameters. Thisenhanced software gives providers the ability to update thepump’s drug library and to extract data stored in the devicewhile the pump is in use, without interrupting the deliveryof patient medication. Moog believes that creating efficien­cies is critical to the improvement of workflow and the fu­ture of patient care.

The Infusion Therapy MarketMoog is committed to participating in the development andfuture growth of the alternate­site infusion industry. Moogmade the decision to focus initially on the alternate­site in­fusion market and assembled a team of experts with exten­sive market experience to accomplish that goal.

Moog has been—and will continue to be—a member ofthe National Home Infusion Association’s Future of InfusionAdvisory Council (FIAC). As a member of the FIAC, Moogworks directly with the NHIA Board and leaders to set thestrategic direction of NHIA. By having input into the issuesaddressed by the council, Moog strives to be a dedicatedvoice for providers within the industry.

One example is the industry­wide data collection effort,which is supported by the FIAC. Through the collection ofdata, the field can demonstrate cost­effectiveness and qual­ity of home infusion therapy. Continued collaborationamong all industry stakeholders, including the members ofthe FIAC, is vital to the continuation of gathering and pre­senting evidence­based best practices and securing appro­priate reimbursement for quality care.

Moog TodayTo ensure that infusion and enteral therapy providers re­ceive dedicated support and enhanced safety, Moog em­ploys a number of full­time nurses, pharmacists andconsultants from other health care professions. It also sup­ports customers, patients, and caregivers by offering a 24/7hotline staffed by nurses who can help fellow clinicians orpatients any time of the day. The information gained fromthis communication goes into a feedback loop Moog uses

to improve customer knowledge and continuously improveproducts and services.

Infusion and enteral feeding pump therapy are criticalcomponents in the “hospital to home” continuum of pa­tient care. Drug and nutrition delivery in the home environ­ment increases adult and pediatric patients’ comfort andquality of life while reducing the cost of treatment.

There are many challenges facing the home and alternate­site infusion provider, including continued regulatoryscrutiny, escalating labor costs and shortages, patientsafety, and reimbursement of care. By making it easy to cre­ate and implement customized protocols and improving de­livery of information through electronic communications,Moog continues to respond to the evolving critical needs ofits patients and the future of the enteral feeding and infu­sion therapy market.

For more information on this valued FIAC member,please visit: www.moog.com/medical

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Thirty years ago, Wolfgang Marguerre was sitting in a modestoffice in Paris when the decision was made to establish Oc­tapharma. It was his vision to create a company that would

provide patients with human protein therapies that set the bench­mark for safety and quality.

Today, Octapharma is still a family­owned business with the con­tinued goal of helping people live better lives. At the same time ithas become the largest privately owned plasma products companyin the world. Headquartered in Lachen, Switzerland, Octapharmaemploys over 5,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States,where Octapharma USA is located in Hoboken, New Jersey.

“Clearly, Octapharma has seized the global opportunity, but our goal is still the same,” says Octapharma USA PresidentFlemming Nielsen. “Patients always come first. In the end, doing what is right for patients has always turned out right forOctapharma as a business. Our goal is to be the leading global manufacturer in the plasma industry with an innovative prod­uct portfolio that focuses on quality, efficacy, innovation, and disease management concepts.”

Broad PortfolioWith a broad and expanding pipeline, Octapharma’s core business is the development, production, and sale of high­qualityhuman protein therapies from both human plasma and human cell lines. The company’s clinical focus areas are:

• Hematology (coagulation disorders)• Immunotherapy (immune disorders)• Intensive care and emergency medicine

In the U.S., Octapharma’s growing product portfolio includes octagam® [Immunoglobulin Intravenous(human) 5% liquid preparation]; Octaplas®, a solvent/ detergent (S/D) treated, pooled human plasma; wilate®

(von Willebrand Factor/Factor VIII Concentrate, human); and Albumin.Octapharma has been committed to patient care and medical innovation since those first days in Paris, de­

termined to bring patients and the medical community life­enhancing and life­saving therapies. Today Octapharmacontinues to support scientific collaboration in many ways—all with the goal of improving patient quality of life.

“Octapharma’s unique approach, from human to human, has always been the patient­centered standard that sets usapart,” according to Nielsen. “Our mission—the safe and optimal use of human proteins—emphasizes our belief that ther­apies from human plasma and human cell lines can produce optimal patient benefits. We carry that mission forward inmany ways—from innovative therapies to collaboration with the patient and scientific communities. Patient safety andquality of life will always be our first priority.”

Octapharma has continuously developed ever­more sophisticated technologies in order to provide effective and safebiopharmaceuticals. The underlying principle for Octapharma’s research and development program is to create therapiesbased on human proteins, either purified from human plasma or produced by recombinant technologies, applied to humancell lines.

“Human proteins have been developed over millions of years of evolution and nature has done a very thorough job ofoptimizing their efficiency and reducing side effects,” Nielsen notes. “Octapharma is focused on bringing these proteinsto patients in the form of life­saving therapeutics in a way that respects the integrity of the proteins, but at the same timeensures that any potential virus transmission is avoided. With an experienced research and development team, Octapharma

FIAC ProfileOctapharma USA

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is constantly investing in future therapies as well as optimiz­ing purification and virus inactivation methods.”

Research for the FutureOctapharma’s research and development program, locatedin Austria, Germany, and Sweden, has developed an exten­sive R&D pipeline. Among the first to develop human pro­teins based on recombinant technologies and human celllines, Octapharma recently opened a $32.5 million researchfacility dedicated to recombinant protein drug developmentin Heidelberg, Germany, a university city just a few minutesfrom Wolfgang Marguerre’s birthplace and childhoodschool. Octapharma’s innovative research in human recom­binant technology and the development of the clinical pro­duction of these new products are housed in thestate­of­the­art, near 110,000­square­foot Heidelberg facil­ity.

“The work being carried out in Heidelberg will have inter­national reach,” says Nielsen. “Through the use of humancell lines Octapharma aims to create more compatible med­icines with improved tolerability and reduced immunogenic­ity.”

Octapharma’s recombinant proteins are produced in cul­tured human cells. Human recombinant proteins producedin human cell lines show identical properties to the sameprotein derived directly from human tissues and blood. Theyare, therefore, expected to show improved tolerance in pa­tients compared to currently available hamster cell­derivedrecombinant products.

Octapharma’s first recombinant product, blood clottingFactor VIII (Human­cl rhFVIII), has successfully completedClinical Phase III, with other research projects in differentstages of development. Current research projects includehuman­derived growth factor, fibrinogen, and recombinantgranulocyte­colony stimulating factor, among others.

“The company’s impressive investment in the futurethrough recombinant research and development just under­scores the fact that 30 years later, we still have the samemission,” says Nielsen. “Safety, integrity, quality, responsi­bility, loyalty – these have been our guiding principles forthe last three decades. And they remain central to our cul­ture as we move forward.”

Octapharma’s worldwide facilities also include six state­of­the­art production plants in Austria, France, Germany,Sweden, and Mexico; 54 plasma donation centers in the U.S.and Europe; and 37 subsidiaries and representative offices.

While still a relatively young company, Octapharma hasan impressive history. Octapharma was a pioneer in:

• The application of the solvent detergent (SD) virus in­activation method to routine production

• Developing high­purity, virus inactivated Factor VIIIand Factor IX concentrates

• Developing an unmodified human recombinant FVIIIfrom a human cell­line

• Developing a liquid immunoglobulin preparation • Manufacturing virus­inactivated plasma for transfu­

sion

Collaborating with Patients andCliniciansOctapharma did not enter the U.S. until 2004, but has suc­cessfully grown market share each year. The company’s suc­cess is mainly due to the collaborations it has establishedwith the patient and clinical communities. Octapharma hasworked to maintain strong collaborative relationships withU.S. patient and professional organizations, including NHIA,Immune Deficiency Foundation, Jeffrey Modell Foundation,Neuropathy Association, National Hemophilia Foundation,Plasma Protein Therapeutics Association, and the ClinicalImmunology Society.

“The U.S. is a key market in Octapharma’s strategic growthplans,” according to Nielsen. “The U.S. is vital to our futureas a company and our product portfolio is growing with themost recent addition being the launch of Octaplas® earlierthis year. We anticipate that 2013 will be a great year for Oc­tapharma in the U.S.”

As the company continues to grow in the U.S., Octapharmaremains committed to fulfilling patient needs. For example, in2012 Octapharma made unrestricted quantities of octagam 5%available to participating 340B facilities. The 340B Drug PricingProgram provides discounted therapies to safety net hospitalsand similar medical providers.

“Octapharma is committed to providing therapies to treatlife­threatening conditions for patients, including those whohave historically faced challenges accessing IVIG,” saysNielsen. “We are focused on serving patient needs, regard­less of where they receive treatment. Our first priority todayand tomorrow is to help patients access life­enhancing andlife­saving therapies.

For more information on this valued FIAC member,please visit: www.octapharma.us

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Smiths Medical ASD, Inc., has been in the business of “bring­ing technology to life” since the early 1980s. It is part ofSmiths Group, a global company that applies advanced tech­

nologies for markets in threat and contraband detection, energy,medical devices, communications, and engineeredcomponents. Smiths Group employs around 22,000 people in morethan 50 countries.

As a supplier of specialized medical devices and equipment forglobal markets, Smiths Medical focuses on the medication delivery,vital care, and safety device market segments. It is best known for its CADD® and Medfusion® platforms, which it continuesto build upon. Working across the continuum of care, Smiths Medical is able to see the big picture in health care. Being abroad­based medical device company allows an expansive view. Yet, through its long­standing customer relationships, it isable to remain in touch with many evolving markets and design products that meet needs as they evolve.

Big PictureSmiths Medical’s alternate­site customers can benefit from the fact that technologies are often designed for and testedin—the acute care sector first. The company develops features for its infusion technology in the hospital that can be trans­ferrable into the alternate­site arena. Patient safety features are a primary focus. CADD® pumps have always been designedwith error reduction in mind, such as the company’s tamper­proof medication cassette reservoir system and scrolling—rather than numeric—keypad.

In its next evolution, the new CADD®­Solis VIP Ambulatory Infusion System, was designed specifically for the homeinfusion patient and supports error­reduction initiatives within the home infusion environment. The Solis VIP is a ver­satile pump for multiple therapies, including TPN, intermittent, continuous, PCA, and step. The large, therapy­specificcolor screens differentiate each delivery mode and provide intuitive, easy­to­use navigation. The Windows®­based PCAdministrator software allows home care pharmacists to enter and store custom therapy­based protocols, drug names,concentrations, and dosing limits.

“We appreciate not getting so far ahead that the customer isn’t there yet. So, for our next generation of pumps, we’reengineering devices that are scalable,” says Martha Sewall, Vice President Clinical Marketing and Scientific Affairs. “Watch­ing how issues evolve in the hospital setting gives us perspective,” she observes. For example, Sewall states, “patient safetyinitiatives drove demands for smart pump technology and are driving demands for integrating infusion data into electronichealth records.”

The data not only allows for accurate documentation, it can eventually be used in an aggregatedform to study and improve processes, she adds. “We foresee the collection of data contin­uing into the home,” says Sewall, “but our home infusion customers need routes of com­munication and hardware to support it.”

Infusion pumps meet those criteria, says Sewall. An electronic physician’s order tied tothe pump can be carried out, sent to pharmacy and documented in a patient record, andthen billed electronically, she explains. In its next generation of pump design, Smiths is“trying to anticipate medication safety, patient care, and workflow management,” accord­

FIAC ProfileSmiths Medical ASD, Inc.

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ing to Sewall. “We see the trend from the patient perspec­tive, the clinical provider perspective, and the IT providerperspective since our products touch all three.”

Trends and the FutureAside from helping improve patient safety and improveworkflow, the use of data in higher­tech health care deliveryspeaks to several overarching industry trends, according toSewall. “Baby boomers are just now reaching the age wherethey will require more healthcare interventions,” sheexplains. “They, and thegenerations behindthem, are increas­ingly tech­savvy,”says Sewall, and theywill all be asking, “DoI really have to be inthe hospital?” “Oursense of the market isthat patients will in­creasingly push for carein the home,” asserts Sewall. “We are even hearing thatfrom our hospital customers.”

“We are anticipating that home infusion will move tohigher­tech devices to improve business operations,” addsSewall. Technology that evolves with the same eye towardpatient data management mentioned earlier will allowproviders to handle more patients across a larger geo­graphic area, she says. “All while providing the same highlevel of quality care.”

The success of this model, however, hinges on building astronger reimbursement base for the alternate­site infusionfield. For that, the field will need to come together todemonstrate its value. And, the best way to demonstratevalue, according to Sewall, is through data. “We have ap­preciated all along the need to articulate the value of homeinfusion in the continuum of care,” asserts Sewall. “SmithsMedical is committed to that goal through our membershipin NHIA’s Future of Infusion Advisory Council (FIAC) and ourother efforts to drive health care policy.”

“We understand the challenges from a business stand­point,” says Sewall, “but a robust system to manage pa­tients at home effectively is one key to collecting the datawe need to back up the value proposition.”

Partners in AdvocacyAdvancing the value proposition to policymakers in Wash­ington, D.C., is critical to expanding Medicare coverage forhome infusion, according to Chris Swonger, Senior VicePresident of Government Relations for Smiths Group.Swonger has worked closely with NHIA’s Advocacy Team toreach members of Congress and the Administration. “Wehave really pressed the issue on the Hill, trying to raiseawareness,” he says. “A meaningful benefit would improvepatient care and generate cost savings.” It’s a model thatworks in the private insurance market, he notes, and itmakes sense for Medicare beneficiaries.

NHIA’s most recent effort—working with a health careconsulting firm—to quantify the cost savings is vital,Swonger adds. “NHIA has been pushing this common­sense solution for a long time,” he says. “But in thisbudget environment, it’s clear we need data to under­score the cost savings.”

Whenever we can move patients out of the hospital, it’sa win­win, continues Swonger, pointing out. “Smiths’ prod­ucts provide technology to improve patient care. Over thelast 20 to 25 years, the technology has evolved to allow usto transition patients into the home with a variety of bene­fits, including decreased risk of infectious disease.” It’s thisshared interest in improving patient care that is the foun­dation of Smiths’ relationship with NHIA, he adds. “We areinvested in the success of NHIA.”

For more information on this valued FIAC member,please visit: www.smiths­medical.com

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Baxter Healthcare Corporation

B. Braun Medical, Inc.

Cubist Pharmaceuticals

Hospira Worldwide, Inc.

Innovatix, LLC

Managed Health Care Associates Inc.

Moog Medical Device Group

Smiths Medical

Medical Specialties Distributors, LLC

Octapharma USA

NHIA Future of Infusion Advisory Council The NHIA Future of Infusion Advisory Council (FIAC) brings together outstanding manufacturing and service companieswho have pledged leadership, policy, and financial support to the National Home Infusion Association (NHIA). TheCouncil works closely with the NHIA Board, leadership staff, and provider members to address the most critical issues,opportunities and challenges facing the home and specialty infusion industry—and this publication provides informa­tive organizational profiles for each of the 10 2012 – 2013 FIAC member companies.